
REMS Product Management
Hawaii Specialty Pharmacy can support and manage a REMS program aligned with the goals of the manufacturer. We offer:
- Project management responsible for the internal cross function for the program
- Identification of multiple REMS strategies which anticipate all potential scenarios, including FDA responses
- Leveraging of efficiencies to maximize performance and mitigate costs
- Anticipation of future needs and plan for scalability
- Timely reporting of information to manufacturer
- Ongoing analysis of program effectiveness and needs for improvement
- Preparation for auditing
- Hawaii Specialty Pharmacy has experience managing REMS programs across multiple disease states, including programs ranging from medication guides to ones requiring Elements to Assure Safe Use (ETASU).